REDCap Database Setup: An Introduction

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Creation Date 16.01.2020. This document by CTU Bern is licensed under a Creative Commons Attribution 4.0 International License

CTU Bern

Data Management

REDCap Database Setup:

An Introduction

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2 Creation Date 16.01.2020. This document by CTU Bern is licensed under a Creative Commons Attribution 4.0 International License

1. Human Research Act (HRA)

2. Clinical Data Management Systems (CDMS)

3. REDCap Services Models at CTU Bern

4. REDCap: how it works…step by step

5. Principles of CRF Design

Introduction to REDCap

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Human Research Act (HRA)

Handling of health-related personal data

according to the Human Research Act

a) Restrict the handling of health-related personal data to those persons who require this data to fulfill their duties

=> Personalized Login

b) Prevent unauthorized or accidental disclosure, alteration, deletion and copying of the health-related personal data

=> Control of access levels

c) Document all processing operations which are essential to ensure traceability

=> Audit-Trail

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Human Research Act (HRA)

Excel is not a HRA-compliant solution

a) Handling of health-related personal data must be restricted to the individuals who need these data to fulfill their duties

=> Login (password protection,no personalized access)

b) Unauthorized or accidental disclosure, alteration, deletion and copying of the health-realted personal data must be prevented

=> Control of access levels (not possible)

c) All processing operations which are essential to ensure traceability must be documented

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1. Human Research Act (HRA)

2. Clinical Data Management Systems (CDMS)

3. REDCap Services Models at CTU Bern

4. REDCap: how it works…step by step

5. Principles of CRF Design

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Clinical Data Management System (CDMS)

− Computerized system designed for the collection of clinical data (i.e. CRF data) in electronic format.

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CDMS main characteristics

− Project setup interface

− Data entry interface

− Data entry status overview

− User management interface

− Audit trail

− Predefined data types ensuring controlled data entry

− Real time data validation

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HRA-compliant CDMS used at CTU Bern

− REDCap - recommended for simple study designs

• Simple visit plan (i.e. no/few unscheduled visits, no treatment arms)

• Simple data monitoring functionalities

− secuTrial - recommended for more complex study designs

• Minimization (i.e. adaptive randomization)

• Complex visit plan (i.e. unscheduled visits, treatment arms, etc.)

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REDCap, a web-based CDMS

− Research Electronic Data Capture

− Developed by Vanderbilt University, Nashville, USA in 2004

− Compliant to GCP & HRA

− Free license for non-commercial purposes

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REDCap – Key facts

− Easy to learn and easy to work with

− Offline CRF creation

− Patient-completed surveys

− Data import (from Excel)

− Offline data entry (mobile App)

− Double data entry (inexperienced staff, poor eCRF quality)

− Online randomization (static randomization only)

− Data queries can be generated, handled and resolved online

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1. Human Research Act (HRA)

2. Clinical Data Management Systems (CDMS)

3. REDCap Services Models at CTU Bern

4. REDCap: how it works…step by step

5. Principles of CRF Design

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REDCap Services Models at CTU Bern

CTU Bern offers two REDCap Service Models

for Inselspital and University of Bern

− REDCap Full Service Project

• CTU Bern builds up the REDCap database according to the specifications from the PI (paper CRFs, Study Protocol, etc.)

• PI tests the database until she/he is satisfied with database setup

− REDCap Light Service Project

• IT infrastructure (daily back-up, secure system, frequent updates)

• PI/database developer attends one of our monthly REDCap training sessions (2 hours)

• Deployment of database

• Costs: starting from 1500.- CHF

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REDCap Light*

− IT infrastructure (daily back-up, secure system, frequent updates) − Attendance of our monthly REDCap training sessions (2 hours)

− Deployment of database − Costs: starting from 1500.- CHF

− Annual costs: user management and super user support after deployment

Data management - Support - Review of DB - Data Import Monitoring Statistics - Randomization list - Analysis - Review of DB

Light Service Package

Additional Service Options

(agreed in the costing)

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REDCap Light Service Project

First Steps

− Contact CTU Bern (e.g. when scope of study is defined)

− CTU Bern asks PI to provide study Sponsor contact’s details as well as other study- and database-specific information

− CTU Bern creates a cost estimate and sends it to study Sponsor for approval/signature

− CTU Bern creates a new REDCap Project and provides study PI/Database developer with access rights

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Contact CTU Bern

− CTU Bern

Mittelstrasse 43 3012 Bern

Switzerland

− CTU Bern Website www.ctu.unibe.ch

− Data Management Support [email protected]

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CTU Bern: Data Management Division

Eva Joho

Yves Bochud Muriel

Helmers WegmannMiriam

Sheila Appadoo +

Annetta Redmann

Christiane

Pelzer WegmüllerSelina KünzliLea

Mario Moser

Dominik Güntensperger

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1. Human Research Act (HRA)

2. Clinical Data Management Systems (CDMS)

3. REDCap Services Models at CTU Bern

4. REDCap: how it works…step by step

5. Principles of CRF Design

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REDCap: how it works…step by step

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1. Human Research Act (HRA)

2. Clinical Data Management Systems (CDMS)

3. REDCap Services Models at CTU Bern

4. REDCap: how it works…step by step

5. Principles of CRF Design

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Principles of CRF Design

− Open-ended vs. closed-ended response format

− Validation and data entry instructions

− Multiple- vs. single-answer fields

− Complete, consistent and accurate datasets

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Principles of CRF Design

Literature

− Society for Clinical Data Management (SCDM), www.scdm.org

(e.g. Good Clinical Data Management Practice, GCDMP)

− European Clinical Research Infrastructure Network (ECRIN), www.ecrin.org

(e.g. Requirements for Certification of ECRIN Data Centers)

− Association for Clinical Data Management (ACDM), www.acdm.org.uk − Swiss Clinical Trial Organization (SCTO), www.scto.ch

(e.g. Data Management Guidelines)

− Prokscha, S: Practical Guide to Clinical Data Management, 2012. ISBN 978-1-439-84829-6

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Addendum I

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REDCap: How it works… Step by step

Login

− https://redcap.ctu.unibe.ch − Login = Username + password

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Homepage

− Home

− My Projects

− Training Resources (Videos)

− Help & FAQ

− Send-It

• Secure data transfer application

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Project setup – Main project settings

− Main project settings

• Longitudinal data collection? (Use longitudinal data collection with repeating forms?)

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Project setup – CRF creation

− Design your data collection instruments

• Online Designer (online CRF creation => user-friendly)

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Clinical Data Management System (CDMS) Note

Important when working with .CSV (Data

Dictionary / Export)

Make sure your computer settings are set correctly to read the .csv

Go to control panel – change date, time, or number formats – Additional settings – List separtator needs to be «,» not «;»!

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Online Designer – Field creation

− Field Type − Field Label − Choices − Variable Name − Validation − Required? − Identifier? − Custom Alignment − Field Note − Field Annotation Edit/Add Field

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Field creation – Predefined field types

− Text Box, validated

• Numeric fields (validation required)

• Dates (validation required)

− Text Box, unvalidated*: single-line text box

− Notes Box*: large text box for longer text

− Dropdown List / Radio Buttons: multiple choices, single answer

− Checkboxes*: multiple answers possible

− Calculated Fields*: perform calculations (numbers/dates only)

− File Upload: document upload, e.g. PDF file (light files only)

− Slider / Visual Analogue Scale: coded from 0 to100

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Field creation – Field label

− The field label contains the question text

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Field creation – Choices

− Multiple-choices fields

code first choice as 1, increment by 1 with every added choice

− Special values

• 1, yes / true / positive / etc.

• 0, no / none / false / negative / etc.

• 77, not applicable

• 88, other / etc.

• 99, unknown / not available / not done / etc.

Use consistent coding within your project!

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Field creation – Variable name

− Must be unique within a project

− Should be short and meaningful (do NOT use autonaming)

− Recommended length: < 26 characters

− Must start with a lowercase and can only contain letters, numbers and underscores. All letters must be lowercase.

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Field creation – Validation

− Main validation formats

• Numeric Fields

 Integer (whole number)

 Number (1, 2, 3 or 4 decimal place(s))

 Number (every type of numbers is tolerated)

• Dates / Time

 DD-MM-YYYY

 HH:MM

• Text

 Email

 Letters only (whitespaces not tolerated!)

− Range values (for numeric and date fields only)

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Field creation – Required fields & Identifiers

− Required fields: If one or several required fields have no value while saving your data

entry form, REDCap will send you a warning but will not prevent you from saving your work (≠ survey).

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Field creation – Field note

− Field note: Is used to give clear data entry instructions. Particularly useful for numeric

and date fields (REDCap does not tolerate any error in validation type).

• Validation format

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Online Designer – Branching logic I

− Branching logic: Branching logic enables you to display a field only if a specific (set of)

condition is met.

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Online Designer – Branching logic II

− Branching logic can be implemented by:

• programming

• “drag & drop”

− Branching logic cannot be tested without entering test data (Rules can however now be tested within the Online Designer)

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Online Designer – Record ID

− The first field of the first form is the Record ID. DON’T CHANGE IT! This field allows REDCap to uniquely identify each record (patient).

− If you want to collect an additional identifier (i.e. patient ID), please create a new field (and, eventually, set it as secondary unique field).

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Project setup – Define my events

− For longitudinal data collection only

• Define your events by entering their name

• Possibility to define several arm(s), i.e. groups of events/visits. (e.g. cases vs. controls)

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Project Setup – Event table

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Project Setup – Optional modules and

customizations

− Optional modules and customizations

• Repeatable instruments and events

 Repeated instruments: for both classic and longitudinal projects

 Repeated events: for longitudinal projects only

• Auto-numbering for records

 Please keep it enabled!

• Scheduling module (i.e. use of REDCap internal calendar)

 For longitudinal projects only

• Randomization module

 For randomized trials only

• E-mail field to use for invitations to survey participants

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Optional modules – Repeatable instruments

and events

− Specify the instruments/events that shall be repeatable

• Not repeating vs. Repeat Instruments vs. Repeat Entire Event

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Optional modules –

Repeatable instruments and events

Will add a new event

Will add a new instrument

For more details or

explanations, please watch the respective training video!

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Randomization module – Model definition

− Define your randomization model

− usually done by CTU Bern, experience required • Stratification factors (optional)

• Group/Site (optional)

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Randomization module – Allocation tables

− Two allocation tables will be uploaded

1 for development mode 1 for production mode

Study sites: Bern (19), Aarau (20) Treatments: 1, 2 or 3

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Project Setup – Additional customizations

− Additional Customizations

• Secondary unique field (e.g. patient ID)

• Data error resolution systems (Monitoring)

 Field Comment Log

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General: Changing the format (color, text) of

the form, field or text display using HTML

− You can find good examples in “REDCap Help & FAQ”:

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Database deployment

Move your project to production status

− CTU Bern will move your project to production mode, after your database works the way you expect (i.e. once thoroughly tested).

− On request CTU Bern will review you database before deployment.

− All test data will be deleted. You are now ready to collect “real” data.

− Once in production mode, minor structural changes can be implemented in Draft Mode (collection of data is still possible while implementing changes in Draft Mode).

− Changes are not executed instantaneously anymore but must be approved by CTU Bern

− With REDCap Light: CTU Bern does not review your changes! Be careful if changes

provoke data damage or loss.

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Data Collection – Add / Edit Records

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Data Collection – Record Status Dashboard

− Record Status Dashboard

• Form status icon (can be set manually at the bottom of each data entry form)

 Red = Data entry incomplete

 Yellow = Data entry complete, form unverified (optional)

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Applications

− Data Exports, Reports, and Stats (Analysis)

• Data can be exported to Excel and several statistics softwares (R, STATA, SAS, SPSS)

• Possibility to build up online Reports which can be exported.

− Data Quality and Resolve Issues (Monitoring)

• Predefined rules to identify missing or inconsistent data

• Custom rules can be implemented

• Rules can be executed at data entry (real-time check), separately or all at the same time

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Addendum II

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REDCap: Principles of CRF Design

Open-Ended Response Format

− Free text responses

− Details are captured

− Burden of participants might be increased

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Closed-ended Response Format

− Pre-defined (limited) responses

− Easy to complete

− Branching possible

− Coding done in advance

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Open- vs. Closed-Ended Response Format

Take Home Message

Use open-ended response format only if you can not foresee how responses will look like (e.g. comments)

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Validation & Data Entry Instructions

− If applicable, indicate the units in the field label (e.g. mmHg)

− Validate every numeric field with a predefined validation format (e.g. integer)

− Set min. and max. range values (e.g. min=50, max=250)

− Indicate the field validation format as well as the range values in field note

Take Home Message:

Numeric fields

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Validation & Data Entry Instructions

− Validate every date field with a predefined validation format (e.g. D-M-Y)

− Set min. and max. range values (e.g. min=01-01-2017, max=31-12-2019)

− Indicate the field validation format as well as the range values in field note

Take Home Message:

Date fields

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Multiple-answers fields

− Fast data entry

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Single answers

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Multiple vs. single answer fields

For primary endpoints, always use (matrices of) single-answer fields (e.g. yes/no fields) instead of multiple-answers fields (i.e. checkboxes)!

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Complete, consistent and accurate datasets

− What if this patient was never tested for HIV?

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Complete, consistent and accurate datasets

For every single-answer field where it is applicable, add a choice “Unknown/Not done/etc”.

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Complete, consistent and accurate datasets

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Complete, consistent and accurate datasets

For every multiple-choice field, where it is applicable, add a choice “Other” and branch it with a text box/note box

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Complete, consistent and accurate datasets

− What if this patient does not smoke?

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Complete, consistent and accurate datasets

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